FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
K Number: K854568
·
Decision Dec 2, 1985
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
3
Applicant Total
31
Review Days
18
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Basic Information
- Device Name
- V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
- K Number
- K854568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American V. Mueller
- Date Received
- November 14, 1985
- Decision Date
- December 2, 1985
- Product Code
- GEF
- 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 |
|---|---|---|---|
| GEF | Applier, Staple, Surgical, | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEF), ordered by most recent decision date.
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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 |
| 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 |
| K850947 | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS | Apr 17, 1985 | Substantially Equivalent |