Endoscopic Diagnostic & Treatment System (Modification)
FDA 510(k) K120766 · Prosurg, Inc.
510(k) numberK120766
Submission
- Device name
- Endoscopic Diagnostic & Treatment System (Modification)
- Applicant
- Prosurg, Inc.
San Jose, CA, US - Received
- March 13, 2012
- Decision date
- September 11, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FAJ – Cystoscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FAJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260649 | OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr.…FAJ · Traditional | Olympus Winter & Ibe GmbH | 05/21/2026SE |
| K253696 | CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse…FAJ · Traditional | Verathon Medical (Canada) Ulc | 05/11/2026SE |
| K253892 | Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm…FAJ · Traditional | Strauss Surgical USA | 04/16/2026SE |
| K253905 | PrimeSight UltraView SystemFAJ · Traditional | Cogentix Medical, Inc. | 04/07/2026SE |
| K260271 | Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsFAJ · Traditional | American Medical Endoscopy, Inc. | 03/27/2026SE |
| K253226 | UV5000W HandleFAJ · Special | Uroviu Corporation | 10/23/2025SE |
| K251140 | Zenflow Spring ScopeFAJ · Traditional | Zenflow, Inc. | 09/23/2025SE |
| K252598 | Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)FAJ · Special | Shanghai AnQing Medical Instrument Co., Ltd. | 09/15/2025SE |
| K250797 | UV5000 HandleFAJ · Traditional | Uroviu Corporation | 09/11/2025SE |
| K243653 | KARL STORZ HOPKINS Telescopes for UrologyFAJ · Traditional | Karl Storz SE & CO. KG | 08/13/2025SE |
More from Karl Storz SE & CO. KG
| 510(k) | Device | Decision |
|---|---|---|
| K152511 | Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/…HRX · Traditional | 07/11/2016SE |
| K152466 | Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)EOQ · Traditional | 05/19/2016SE |
| K152619 | Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible)GCJ · Traditional | 04/29/2016SE |
| K072528 | Adjustable Bone Plates Bioabsorbable, Self Compression Bone Fixation System & AccessoriesJEY · Traditional | 12/28/2007SE |
| K071138 | Cranioclamp Bioabsorbable Cranial Bone Flap Fixation SystemGXR · Traditional | 08/15/2007SE |
| K070737 | Xsorb Bioabsorbable Craniofacial Bone Fixation System & AccessoriesJEY · Traditional | 07/25/2007SE |
| K070846 | Minisling Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring SystemFTL · Traditional | 07/02/2007SE |
| K060326 | Lasertx - Diode Laser & Delivery SystemGEX · Traditional | 04/05/2006SE |
| K050488 | Turbt-Rf Electrodes and Electrosurgical DevicesFAS · Traditional | 04/01/2005SE |
| K042780 | Neoscope - Endoscopic Diagnostic & Treatment SystemFAJ · Traditional | 02/03/2005SE |
Questions and answers
When was Endoscopic Diagnostic & Treatment System (Modification) cleared by the FDA?
Endoscopic Diagnostic & Treatment System (Modification) (K120766) received a 510(k) decision of Substantially Equivalent on September 11, 2012, 182 days after the submission was received.
What is the product code of K120766?
The FDA product code is FAJ – Cystoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.