FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OBGRIP AND UNITIPS(TM)
K Number: K930617
·
Decision Aug 11, 1993
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
184
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Basic Information
- Device Name
- OBGRIP AND UNITIPS(TM)
- K Number
- K930617
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unisurge, Inc.
- Date Received
- February 8, 1993
- Decision Date
- August 11, 1993
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Unisurge, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943502 | UNIGRIP | Oct 7, 1994 | Substantially Equivalent |
| K933720 | INSTRUMENT ACTUATING DEVICE (IAD) | Nov 12, 1993 | Substantially Equivalent |
| K930605 | APPLIER, SURGICAL, CLIP | Oct 8, 1993 | Substantially Equivalent |
| K925917 | UNICHANNEL(TM SURGICAL GRASPER | Aug 10, 1993 | Substantially Equivalent |
| K932604 | UNIGRIP-FH SURGICAL HANDPIECE/LAPAROSCOPIC | Aug 10, 1993 | Substantially Equivalent |
| K930809 | UNITIPS | Aug 10, 1993 | Substantially Equivalent |
| K925882 | UNITIPS SURGICAL INSTRUMENTS | Aug 10, 1993 | Substantially Equivalent |
| K926341 | UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT | May 17, 1993 | Substantially Equivalent |
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Apr 20, 1993 | Substantially Equivalent |
| K914923 | UNISURGE DISPOSABLE TROCAR | Sep 21, 1992 | Substantially Equivalent |