FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PUNCH SURGICAL
K Number: K933772
·
Decision Feb 1, 1994
Classifications
1
FEI Numbers
1106
Registration Numbers
1106
Same Product Code
57
Applicant Total
8
Review Days
187
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Basic Information
- Device Name
- PUNCH SURGICAL
- K Number
- K933772
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mahe-Medizintechnik
- Date Received
- July 29, 1993
- Decision Date
- February 1, 1994
- Product Code
- LXH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | FDA class 1 | Orthopedic |
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Other Clearances by Mahe-Medizintechnik
| K Number | Device Name | ||
|---|---|---|---|
| K942821 | MAHE INSTRUMENTS | Nov 2, 1994 | Substantially Equivalent |
| K942819 | TROCAR WITH SHIELD | Aug 23, 1994 | Substantially Equivalent |
| K933768 | COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES | Jun 27, 1994 | Substantially Equivalent |
| K933767 | FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY | May 26, 1994 | Substantially Equivalent |
| K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | Mar 23, 1994 | Substantially Equivalent |
| K935442 | MAHE INSTRUMENTS | Mar 14, 1994 | Substantially Equivalent |
| K925624 | MICROSURGICAL INSTRUMENTS | Jul 22, 1993 | Substantially Equivalent |