510(k) K871978
- Device
- CODMAN FLEXIBLE ENDOSCOPE
- Applicant
- Codman & Shurtleff, Inc.
- 510(k) number
- K871978
- Product code
- GCQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-25
- Date received
- 1987-05-22
- Regulation
- 876.1500
- Classification name
- Endoscope, Flexible
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS J COURAGE
- Address
- 41 Pacella Park Dr. Randolph Industrial Park Randolph MA US 02368 02368
FDA Registration Numbers#
- 2032521
- 3013445147
- 3009756153
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GCQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920979 | CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) | Codman & Shurtleff, Inc. | 1993-03-23 |
| K900894 | MEDILASE SERIES 2100 ENDOSCOPE | Medical Laser, Inc. | 1990-06-22 |
| K864960 | TV-ENDOSCOPE, UPPER & LOWER GASTROINTESTINAL APPL. | Cooper Lasersonics, Inc. | 1987-02-10 |
| K860771 | VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE | Van-Tec, Inc. | 1986-04-23 |
Legacy Summary#
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FDA Review#
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