FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TIP OFF FORCEPS
K Number: K854541
·
Decision Dec 17, 1985
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
103
Applicant Total
5
Review Days
34
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
- TIP OFF FORCEPS
- K Number
- K854541
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Keller Instruments, Inc.
- Date Received
- November 13, 1985
- Decision Date
- December 17, 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 Keller Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K841294 | ACU220 CRYO UNIT | Aug 15, 1984 | Substantially Equivalent |
| K841292 | SPECTACLE INDIRECT OPHTHALMOSCOPE | May 9, 1984 | Substantially Equivalent |
| K841293 | PANORAMIC LOUPES - VARIOUS | May 9, 1984 | Substantially Equivalent |
| K823835 | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | Jan 17, 1983 | Substantially Equivalent |