Quiver Laparoscopic Extendable
FDA 510(k) clearance K153472 · decided 2016-06-23
Clearance details
- K-number
- K153472
- Device name
- Quiver Laparoscopic Extendable
- Applicant
- Itl Corporation Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-02
- Decision date
- 2016-06-23
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- HAM
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chelsea Heights, Vic, AU
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| GSU HANDPIECE ADAPTER (K920100) | Beacon Laboratories, Inc. | 1992-02-03 |
| EMC MODEL NO. STATOME 900 (K911353) | Emc Industries | 1991-06-24 |
| ABC HANDPIECE ADAPTER (K901248) | Beacon Laboratories, Inc. | 1990-04-03 |
| LIGHT COAGULATOR LC 250 (K881334) | Nk-Optik GmbH | 1989-11-16 |
| ELECTROSURGICAL COAGULATION SUCTION TUBE (K895337) | New England Surgical Instrument Corp. | 1989-09-15 |
| BEAMER ONE (K894663) | Beacon Laboratories, Inc. | 1989-09-15 |
| B100 DISPOSABLE HANDPIECE (K894762) | Beacon Laboratories, Inc. | 1989-09-15 |
| #875 DISPOSABLE BIOPOLAR CABLE (K884171) | Olsen Electrosurgical, Inc. | 1988-10-24 |
Recalls involving this device
No recalls on record reference this clearance.