510(k) K153472
- Device
- Quiver Laparoscopic Extendable
- Applicant
- ITL Corporation PTY LTD
- 510(k) number
- K153472
- Product code
- HAM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-06-23
- Date received
- 2015-12-02
- Regulation
- 878.4400
- Classification name
- Apparatus, Electrosurgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Emily Rossiter
- Address
- 1/63 Wells Rd. Chelsea Heights, Vic AU 3196 3196
FDA Registration Numbers#
- 3013557562
- 1055236
- 2184009
- 3011137372
- 1047843
- 3004491689
- 1526711
- 1060680
- 1061927
- 1836161
- 9617601
- 1320894
- 1219619
- 3010041511
- 3007748817
- 1319639
- 3013421458
- 3007305485
- 1315756
- 1211998
- 3003898360
- 1319660
- 1043214
- 1220477
- 1643817
- 2212018
- 3013466775
- 3003895930
- 1526534
- 3012494290
- 8030607
- 3010220595
- 2245574
- 1054241
- 3003955307
Source Documents#
Other 510(k) Records For Product Code HAM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000079 | NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777M | Nikomed U.S.A., Inc. | 2000-02-04 |
| K993306 | NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) | Paladin Medical, Inc. | 1999-11-03 |
| K945861 | BERGEN 710 ESU | Bergen Mfg. | 1995-03-01 |
| K913300 | LAPAROSTAT(TM) | Cook Ob/Gyn | 1992-04-02 |
| K920100 | GSU HANDPIECE ADAPTER | Beacon Laboratories, Inc. | 1992-02-03 |
| K911353 | EMC MODEL NO. STATOME 900 | Emc Industries | 1991-06-24 |
| K901248 | ABC HANDPIECE ADAPTER | Beacon Laboratories, Inc. | 1990-04-03 |
| K881334 | LIGHT COAGULATOR LC 250 | Nk-Optik GmbH | 1989-11-16 |
| K895337 | ELECTROSURGICAL COAGULATION SUCTION TUBE | New England Surgical Instrument Corp. | 1989-09-15 |
| K894663 | BEAMER ONE | Beacon Laboratories, Inc. | 1989-09-15 |
| K894762 | B100 DISPOSABLE HANDPIECE | Beacon Laboratories, Inc. | 1989-09-15 |
| K884171 | #875 DISPOSABLE BIOPOLAR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884172 | MODIFIED OLSEN #770 DISPOSABLE HOLSTER | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884173 | #920 DISPOSABLE TUR CABLE | Olsen Electrosurgical, Inc. | 1988-10-24 |
| K884174 | MODIFIED OLSEN 755/756 SWITCHPENS | Olsen Electrosurgical, Inc. | 1988-10-24 |
Legacy Summary#
summary
FDA Review#
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