Imagyn Uroscope
FDA 510(k) K953201 · Imagyn Medical, Inc.
510(k) numberK953201
Submission
- Device name
- Imagyn Uroscope
- Applicant
- Imagyn Medical, Inc.
Laguna Niguel, CA, US - Received
- July 6, 1995
- Decision date
- August 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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).
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| 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
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| K972426 | Microspan Gold Hysteroscope and Microspan Hysteroscope SheathHIH · Traditional | 09/23/1997SE |
| K970750 | Microspan Insemination SystemMFD · Traditional | 05/05/1997SE |
| K971255 | Imagyn Expandable Laparoscopic IntroducerHET · Traditional | 04/21/1997SE |
| K965055 | Imagyn Microlap and Micro Lap-Gold LaparoscopesHET · Traditional | 03/06/1997SE |
| K963580 | Imagyn Falloposcopy SystemMKO · Traditional | 01/31/1997SE |
| K961688 | Microspan HysteroscopeHIH · Traditional | 10/15/1996SE |
| K961506 | Microspan Hysteroscope SheathHIH · Traditional | 07/03/1996SE |
| K952032 | Imagyn Hysteroscope SheathsHIH · Traditional | 10/31/1995SE |
| K951996 | Imagyn EndoscopeGCJ · Traditional | 09/01/1995SE |
| K951974 | Imagyn Endoscope SheathGCJ · Traditional | 08/28/1995SE |
Questions and answers
When was Imagyn Uroscope cleared by the FDA?
Imagyn Uroscope (K953201) received a 510(k) decision of Substantially Equivalent on August 2, 1995, 27 days after the submission was received.
What is the product code of K953201?
The FDA product code is FAJ – Cystoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.