ELMED PNEUMOPERITONEUM NEEDLES
FDA 510(k) clearance K943624 · decided 1994-08-10
Clearance details
- K-number
- K943624
- Device name
- ELMED PNEUMOPERITONEUM NEEDLES
- Applicant
- Henke-Sass, Wolf GmbH
- Decision
- Substantially Equivalent
- Date received
- 1994-07-26
- Decision date
- 1994-08-10
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FHO
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tuttlingen, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Veress Needle (K172120) | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-09-14 |
| VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE (K121370) | Vectec | 2013-08-02 |
| MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (K010779) | Gibbons Surgical Corp. | 2001-04-10 |
| PNEUMO-MATIC INSUFFLATION NEEDLE (K970788) | Apple Medical Corp. | 1997-03-27 |
| ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM (K960574) | Sherwood Medical Co. | 1996-08-05 |
| ACCESS EXPANSION SYSTEM (K951894) | Micro-Medical Devices, Inc. | 1995-06-15 |
| VERRES NEEDLE (K942484) | Linvatec Corp. | 1994-06-24 |
| NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (K930474) | Ranfac, Corp. | 1993-07-23 |
| CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE (K915725) | Clarus Medical Systems, Inc. | 1992-11-16 |
| ENTREE NEEDLE (K914426) | Core Dynamics, Inc. | 1991-11-27 |
| ORIGINEEDLE, MODIFICATION (K913816) | Origin Medsystems, Inc. | 1991-11-08 |
| ORIGINEEDLE(TM) (K904849) | Origin Medsystems, Inc. | 1991-03-29 |
Recalls involving this device
No recalls on record reference this clearance.