Data / Medical devices / United States / Viscot Medical LLC
Viscot Medical LLC: FDA-registered device maker in Denville, NJ, United States, 21 510(k) clearances
Viscot Medical LLC is registered with the FDA (registration 2242656) in Denville, NJ, United States. It lists 17 device types. The FDA files 21 510(k) clearances under its listings, the newest dated October 29, 2013. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2242656
- Address
- 5 Stewart Ct, Denville, NJ, United States, 07834
- Owner or operator
- VISCOT MEDICAL LLC (9068829)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- July 6, 1992
- Registered through
- 2026
- Brand names listed
- 20307, Dukal, MILLIE FEMALE URINAL, O.R. MEDICATION MARKING KIT, R-24, TWENTY-FOUR HOUR C, Tormark, VISMARK SURGICAL SKIN MARKER and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2013 | K130117 | NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS | HOZ | Substantially Equivalent | Network Medical Products, Ltd. | accessdata.fda.gov |
| February 3, 1994 | K935930 | NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSING | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| February 3, 1994 | K935883 | NEUROLOGICAL SPONGES | GDY | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| February 2, 1994 | K935993 | SURGICAL SPONGE X-RAY DETECTABLE | GDY | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 31, 1994 | K935934 | NON ADHERANT BURN PADS | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 31, 1994 | K935911 | PACKING SPONGE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 31, 1994 | K935910 | X-RAY PACKING SPONGE | GDY | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 31, 1994 | K935882 | TONSIL SPONGES | GDY | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 31, 1994 | K935881 | SPECIALTY SPONGES | GDY | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935941 | READY CUT GAUZE GAUZE BOLTS | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935940 | GAUZE SPONGE; DRAIN SPONGE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935939 | GAUZE FLUFF | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935938 | BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLS | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935937 | POST OP SPONGE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935936 | CONFORMING ROLL | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935935 | BURN GAUZE PADS | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935933 | CUSTOM BURN DRESSING | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935932 | BURN COMPRESS | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 14, 1994 | K935931 | NON-WOVEN SPONGE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| January 13, 1994 | K935942 | SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLE | EFQ | Substantially Equivalent | Mcneil Healthcare, Inc. | accessdata.fda.gov |
| December 16, 1993 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | Substantially Equivalent | Arjo Wiggins Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 22, 2012 | 64075 | Class III | Terminated | Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgica | Dual Tip Marker has inconsistent ink flow on the black permanent ink side. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauze/Sponge, Internal, X-Ray Detectable
- All makers of Gauze/Sponge, Internal
- All makers of Label Or Tag, Non-Sterile
- All makers of Dissector, Tonsil
- All makers of Label Or Tag, Sterile
- All makers of Drape, Surgical, Exempt
Updated October 29, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.