FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORCEPS, BIOPSY(NON RIGID)
K Number: K852120
·
Decision Jul 2, 1985
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
103
Applicant Total
8
Review Days
48
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FORCEPS, BIOPSY(NON RIGID)
- K Number
- K852120
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Scholten Surgical Instruments, Inc.
- Date Received
- May 15, 1985
- Decision Date
- July 2, 1985
- Product Code
- GEN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEN | Forceps, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEN), ordered by most recent decision date.
NATURALASE LP ND:YAG LASER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SUTURE REMOVING FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALPATION PROBE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GS-1002 GRASPING FORCEP, 5MM WITH RATCHET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Scholten Surgical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072051 | NOVATOME, MODEL: SU101-50 | Oct 3, 2007 | Substantially Equivalent |
| K900405 | SCHOLTEN FRAME | Mar 1, 1990 | Substantially Equivalent |
| K852331 | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC | Aug 1, 1986 | Substantially Equivalent |
| K852119 | TEMPORARY PACEMAKER GROUND WIRE | Sep 15, 1985 | Substantially Equivalent |
| K852332 | TABLE ACCESSORIES, OPERATING ROOM | Jul 2, 1985 | Substantially Equivalent |
| K852330 | RETRACTOR, SURGICAL | Jun 27, 1985 | Substantially Equivalent |
| K852329 | STAND, OPERATING ROOM | Jun 14, 1985 | Substantially Equivalent |