510(k) K050005 ยท NAY System, Surgical, Computer Controlled Instrument
INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180
| Applicant | Intuitive Surgical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 25, 2005 |
| Received | Jan 3, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2013 | Intuitive Surgical, Inc. 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears)
Manufactured and Distributed by:
Intuitive Surgical
Sunny vale, CA
The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopi Terminated |
NAY | None listed |
| May 29, 2013 | Intuitive Surgical, Inc. Tip Cover Accessory, 8 MM, MCS, box of 10
Product Usage:
The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The Terminated |
NAY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.