FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
K Number: K932118
·
Decision Mar 17, 1994
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
23
Review Days
318
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
- ENDOSCOPIC TRANSMURAL SUTURE NEEDLE SET
- K Number
- K932118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Core Dynamics, Inc.
- Date Received
- May 3, 1993
- Decision Date
- March 17, 1994
- 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 Core Dynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992250 | CORE AUDIBLE TROCAR II | Sep 24, 1999 | Substantially Equivalent |
| K992190 | CORE POUCH | Sep 1, 1999 | Substantially Equivalent |
| K955490 | LAPAROSCOPIC KNITTER | Jan 22, 1996 | Substantially Equivalent |
| K953903 | LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM | Oct 20, 1995 | Substantially Equivalent |
| K953409 | LAPAROSCOPIC TROCAR | Oct 16, 1995 | Substantially Equivalent |
| K950457 | CANNUAL AND TROCAR, SUPERPUBIC | May 5, 1995 | Substantially Equivalent |
| K943172 | CORE DYNAMICS' LAPAROSCOPIC SMOKE ELIMINATOR | Jul 28, 1994 | Substantially Equivalent |
| K935826 | LAPAROSCOPIC/SUCTION/IRRIGATION PROBE | May 18, 1994 | Substantially Equivalent |
| K932021 | ENTREE CANNULA FASCIA ANCHORS | Jan 11, 1994 | Substantially Equivalent |
| K932020 | ENTREE BLUNT TIP TROCAR AND ADAPTER | Jan 11, 1994 | Substantially Equivalent |