Retractor, Surgical
by Scholten Surgical Instruments, Inc.
510(k) K852330
Retractor, Surgical is a medical device (FDA Class I; FDA product code GAD, Retractor) made by Scholten Surgical Instruments, Inc., cleared under FDA 510(k) K852330 on 27 Jun 1985, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852330 | Date27 Jun 1985 | StatusActive |
Official records
- FDA 510(k) database K852330
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GAD
- Device class
- Class I
- Regulation
- 21 CFR Part 878.4800
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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