Company ยท US
Kapp Surgical Instrument, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2021. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 28, 2021 | K200289 | Michler-Kapp Cardiovascular Vent Catheter Kapp Surgical Instrument, Inc. | DWF |
| Nov 9, 2007 | K072216 | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 Kapp Surgical Instrument, Inc. | NEU |
| Jan 13, 2006 | K050384 | KAPP BARI-RING, MODEL KS-BR-2005 Kapp Surgical Instrument, Inc. | NEU |
| Aug 8, 2005 | K050657 | MONDEAL CONTOUR HO SYSTEM Kapp Surgical Instrument, Inc. | HRS |
| Aug 8, 2005 | K050655 | MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 Kapp Surgical Instrument, Inc. | HRS |
| Jul 28, 2004 | K033930 | KAPP CUSTOM ULNAR HEAD WRIST IMPLANT Kapp Surgical Instrument, Inc. | KXE |
| Aug 29, 2003 | K030237 | KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT Kapp Surgical Instrument, Inc. | KWI |
| Nov 8, 1984 | K844177 | COSGROVE MITRAL VALVE RETRACTOR Kapp Surgical Instrument, Inc. | GAD |
| Sep 12, 1984 | K843368 | KAPP SPINAL BUTTON Kapp Surgical Instrument, Inc. | HTN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 19, 2011 | Kapp Surgical Instrument Inc STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box Terminated |
KGT | None listed |
| Jul 7, 2011 | Kapp Surgical Instrument Inc Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box wi Terminated |
NEU | K072216 |