FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNISURGE DISPOSABLE TROCAR
K Number: K914923
·
Decision Sep 21, 1992
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
12
Review Days
322
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
- UNISURGE DISPOSABLE TROCAR
- K Number
- K914923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unisurge, Inc.
- Date Received
- November 4, 1991
- Decision Date
- September 21, 1992
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HET), ordered by most recent decision date.
SIRIUS Endoscope System (PR-SI-1230)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
i-Cut
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIRIUS Endoscope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Video Endoscopy System, 3D Video Endoscopy System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SurroundScope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K926199 | UNICLIP SURGICAL CLIP APPLIER | Apr 20, 1993 | Substantially Equivalent |