Lasersonics Laser Cystoscope Model FCY-6-35
FDA 510(k) K860822 · Cooper Lasersonics, Inc.
510(k) numberK860822
Submission
- Device name
- Lasersonics Laser Cystoscope Model FCY-6-35
- Applicant
- Cooper Lasersonics, Inc.
Santa Clara, CA, US - Received
- March 4, 1986
- Decision date
- April 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K880809 | Illumina Model 55 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880808 | Illumina Model 40 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880807 | Illumina Model 25 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | 04/11/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | 03/24/1988SE |
| K880170 | Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | 03/24/1988SE |
| K880172 | Model 4900 Nd:Yag Laser for Neurosurgery Applica.LKW · Traditional | 03/11/1988SE |
Questions and answers
When was Lasersonics Laser Cystoscope Model FCY-6-35 cleared by the FDA?
Lasersonics Laser Cystoscope Model FCY-6-35 (K860822) received a 510(k) decision of Substantially Equivalent on April 17, 1986, 44 days after the submission was received.
What is the product code of K860822?
The FDA product code is FAJ – Cystoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.