510(k) K970788
- Device
- PNEUMO-MATIC INSUFFLATION NEEDLE
- Applicant
- APPLE MEDICAL CORP.
- 510(k) number
- K970788
- Product code
- FHO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-27
- Date received
- 1997-03-04
- Regulation
- 876.1500
- Classification name
- Pneumoperitoneum Needle
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT W SCHAEFER
- Address
- 580 Main St. Bolton MA US 01740 01740
FDA Registration Numbers#
- 3004605321
- 3021632375
- 3013188547
- 1055236
- 3009495876
- 3030626857
- 1211566
- 3004491689
- 3008191256
- 2647580
- 3011989923
- 1060680
- 3001003398
- 1222773
- 1417592
- 1320894
- 1923569
- 1319639
- 3003139373
- 2916714
- 3010383847
- 3016248634
- 1043214
- 1220477
- 3010806467
- 3007791595
- 2246552
- 3018094310
- 3014611142
- 1219930
- 3012494290
- 3014479313
- 2424366
- 1216677
- 3015497424
- 2320762
- 1054241
- 3008843439
- 3014461810
- 3009212837
- 3009380063
- 9610612
- 3017210488
Source Documents#
Other 510(k) Records For Product Code FHO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172120 | Veress Needle | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 2017-09-14 |
| K121370 | VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE | Vectec | 2013-08-02 |
| K010779 | MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | Gibbons Surgical Corp. | 2001-04-10 |
| K960574 | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | Sherwood Medical Co. | 1996-08-05 |
| K951894 | ACCESS EXPANSION SYSTEM | Micro-Medical Devices, Inc. | 1995-06-15 |
| K943624 | ELMED PNEUMOPERITONEUM NEEDLES | Henke-Sass, Wolf GmbH | 1994-08-10 |
| K942484 | VERRES NEEDLE | Linvatec Corp. | 1994-06-24 |
| K930474 | NEEDLE, PNEUMOPERITONEUM, SPRING LOADED | Ranfac, Corp. | 1993-07-23 |
| K915725 | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE | Clarus Medical Systems, Inc. | 1992-11-16 |
| K914426 | ENTREE NEEDLE | Core Dynamics, Inc. | 1991-11-27 |
| K913816 | ORIGINEEDLE, MODIFICATION | Origin Medsystems, Inc. | 1991-11-08 |
| K904849 | ORIGINEEDLE(TM) | Origin Medsystems, Inc. | 1991-03-29 |
| K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE | United States Surgical, A Division of Tyco Healthc | 1986-10-02 |
| K844619 | ENDONEEDLE | Endotherapeutics | 1985-01-09 |
Legacy Summary#
summary
FDA Review#
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