FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPE ENDOLIGATURE CARRIER
K Number: K915749
·
Decision Oct 20, 1992
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
14
Review Days
302
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Basic Information
- Device Name
- SHARPE ENDOLIGATURE CARRIER
- K Number
- K915749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paladin Medical, Inc.
- Date Received
- December 23, 1991
- Decision Date
- October 20, 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 |
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Other Clearances by Paladin Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | Nov 3, 1999 | Substantially Equivalent |
| K970347 | MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM | Aug 29, 1997 | Substantially Equivalent |
| K971290 | STRATASYS FDM MEDMODELER SYSTEM | Jun 20, 1997 | Substantially Equivalent |
| K964222 | ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING | Dec 20, 1996 | Substantially Equivalent |
| K950054 | ENDO-BEND(TM) SHAVER | Jun 29, 1995 | Substantially Equivalent |
| K935220 | CORE PREVENT MATTRESS MODIFICATION | Nov 29, 1993 | Substantially Equivalent |
| K921015 | SHARPE ENDOSPONGE ASPIIRATOR | May 21, 1993 | Substantially Equivalent |
| K915743 | SHARPE ENDOTENACULUM | May 20, 1993 | Substantially Equivalent |
| K921888 | SHARPE ENDODISSECTOR | Oct 20, 1992 | Substantially Equivalent |
| K915747 | SHARPE ENDOFORCEPS | Oct 20, 1992 | Substantially Equivalent |