Codman Steerable Endoscope (Cat.# 83-1340)
FDA 510(k) K920979 · Codman & Shurtleff, Inc.
510(k) numberK920979
Submission
- Device name
- Codman Steerable Endoscope (Cat.# 83-1340)
- Applicant
- Codman & Shurtleff, Inc.
Attleboro, MA, US - Received
- March 2, 1992
- Decision date
- March 23, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCQ – Endoscope, Flexible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900894 | Medilase Series 2100 EndoscopeGCQ · Traditional | Medical Laser, Inc. | 06/22/1990SE |
| K871978 | Codman Flexible EndoscopeGCQ · Traditional | Codman & Shurtleff, Inc. | 08/25/1987SE |
| K864960 | Tv-Endoscope, Upper & Lower Gastrointestinal Appl.GCQ · Traditional | Cooper Lasersonics, Inc. | 02/10/1987SE |
| K860771 | Van-Tec Disposable Flexible EndoscopeGCQ · Traditional | Van-Tec, Inc. | 04/23/1986SE |
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Questions and answers
When was Codman Steerable Endoscope (Cat.# 83-1340) cleared by the FDA?
Codman Steerable Endoscope (Cat.# 83-1340) (K920979) received a 510(k) decision of Substantially Equivalent on March 23, 1993, 386 days after the submission was received.
What is the product code of K920979?
The FDA product code is GCQ – Endoscope, Flexible, a Class II (moderate risk) device regulated under 21 CFR 876.1500.