Company ยท US
Summit Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2018. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 8 |
| CAC | Apparatus, Autotransfusion | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 |
| CAK | Microfilter, Blood Transfusion | 1 |
| DYX | Lock, Wire, And Ligature, Intraoral | 1 |
| ETD | Tube, Tympanostomy | 1 |
| JYO | Knife, Ear | 1 |
| LFB | Button, Nasal Septal | 1 |
| LRD | Applicator, Ent Drug | 1 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2018 | K180528 | InstruSafe(R) Sterilization Container Summit Medical, Inc. | KCT |
| May 18, 2018 | K173110 | GRAFTSITE Summit Medical , Ltd., GB | BSP |
| Jul 25, 2017 | K170388 | ANCHORMAN Tibial Ligament Fixation Device Summit Medical , Ltd., GB | MBI |
| Apr 11, 2017 | K162046 | MINNE TIES MMF Suture System Summit Medical, Inc. | DYX |
| Aug 18, 2015 | K151166 | Instru-Safe Instrument Protection System Summit Medical, Inc. | KCT |
| Jun 22, 2015 | K150540 | Instru-Safe Instrument Protection System Summit Medical, Inc. | KCT |
| May 29, 2015 | K142768 | Instru-Safe Instrument Protection System Summit Medical, Inc. | KCT |
| Dec 23, 2014 | K142630 | Instru-Safe Instrument Protection System Summit Medical, Inc. | KCT |
| Dec 15, 2014 | K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM Summit Medical, Inc. | KCT |
| Jun 27, 2014 | K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM Summit Medical, Inc. | KCT |
| Mar 13, 2014 | K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM Summit Medical, Inc. | KCT |
| Feb 14, 2003 | K024097 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 Summit Medical , Ltd., GB | CAC |
| Oct 25, 2002 | K022477 | SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET Summit Medical , Ltd., GB | CAK |
| Oct 9, 2002 | K022489 | SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 Summit Medical , Ltd., GB | CAC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2023 | Summit Medical, LLC Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile. Terminated |
LFB | None listed |
| Sep 3, 2015 | Summit Medical, Inc. AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only.
Used as a nasal packing following intranasal surgery Terminated |
LRD | None listed |
| Jun 9, 2014 | Summit Medical, Inc. Armstrong Grommet with wire Otological Ventilation Tube
Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only.
Intended to provide ventilation to the middle ear space through the tympanic mem Terminated |
ETD | K830228 |
| May 14, 2013 | Summit Medical, Inc. Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121
Use to make an incision in the tympanic membrane. Terminated |
JYO | None listed |