FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNICLIP SURGICAL CLIP APPLIER
K Number: K926199
·
Decision Apr 20, 1993
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
13
Applicant Total
12
Review Days
132
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Basic Information
- Device Name
- UNICLIP SURGICAL CLIP APPLIER
- K Number
- K926199
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unisurge, Inc.
- Date Received
- December 9, 1992
- Decision Date
- April 20, 1993
- Product Code
- GDO
- 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 |
|---|---|---|---|
| GDO | Applier, Surgical, Clip | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GDO), ordered by most recent decision date.
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
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DISPOSABLE MULTIPLE LIGATING CLIP
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ETHICON MULTIPLE LIGATING CLIP APPLIER
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·General, Plastic Surgery
HEMOSPENSER CARTRIDGE CAT. NO. 523500-
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K930617 | OBGRIP AND UNITIPS(TM) | Aug 11, 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 |
| K914923 | UNISURGE DISPOSABLE TROCAR | Sep 21, 1992 | Substantially Equivalent |