Imagyn Endoscope Sheath
FDA 510(k) K951974 · Imagyn Medical, Inc.
510(k) numberK951974
Submission
- Device name
- Imagyn Endoscope Sheath
- Applicant
- Imagyn Medical, Inc.
Laguna Niguel, CA, US - Received
- April 27, 1995
- Decision date
- August 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K953201 | Imagyn UroscopeFAJ · Traditional | 08/02/1995SE |
Questions and answers
When was Imagyn Endoscope Sheath cleared by the FDA?
Imagyn Endoscope Sheath (K951974) received a 510(k) decision of Substantially Equivalent on August 28, 1995, 123 days after the submission was received.
What is the product code of K951974?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.