FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANIS LENS IMPLANT FORCEPS #2
K Number: K811658
·
Decision Jun 26, 1981
Classifications
1
FEI Numbers
275
Registration Numbers
276
Same Product Code
43
Applicant Total
31
Review Days
14
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
- ANIS LENS IMPLANT FORCEPS #2
- K Number
- K811658
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American V. Mueller
- Date Received
- June 12, 1981
- Decision Date
- June 26, 1981
- Product Code
- HNR
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HNR | Forceps, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HNR), ordered by most recent decision date.
STEPHENS DISPOSABLE FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
ALCON FOLDING FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
SOFT LENS FOLDING BLOCK
FDA 510(k)
FDA Class 1
·Ophthalmic
PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR
FDA 510(k)
FDA Class 1
·Ophthalmic
MCDONALD FOLDING FORCEPS
FDA 510(k)
FDA Class 1
·Ophthalmic
BRADBURY INTRAOCULAR RETINAL KIT CAT #200
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by American V. Mueller
| K Number | Device Name | ||
|---|---|---|---|
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | Dec 18, 1987 | Substantially Equivalent |
| K873332 | MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM | Sep 8, 1987 | Substantially Equivalent |
| K871685 | HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS | Jun 12, 1987 | Substantially Equivalent |
| K864676 | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM | Dec 29, 1986 | Substantially Equivalent |
| K862772 | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | Aug 18, 1986 | Substantially Equivalent |
| K861471 | V. MUELLER VITAL CLIP-HEMOSTATIC CLIP | Jun 6, 1986 | Substantially Equivalent |
| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | Dec 2, 1985 | Substantially Equivalent |
| K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT | Nov 27, 1985 | Substantially Equivalent |
| K851082 | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES | Jul 22, 1985 | Substantially Equivalent |
| K851974 | V. MUELLER VITAL SKIN STAPLER | Jun 11, 1985 | Substantially Equivalent |