510(k) K050769
- Device
- QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
- Applicant
- Z-MEDICA CORPORATION
- 510(k) number
- K050769
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-04-14
- Date received
- 2005-03-25
- Regulation
- 510(k) Premarket Notification
- Classification name
- Dressing, Wound, Drug
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT V PACKARD
- Address
- 4 Fairfield Blvd. Wallingford CT US 06492 06492
FDA Registration Numbers#
- 3034735187
- 3044819802
- 2244725
- 3015205402
- 3015437221
- 3033589330
- 3002422294
- 3014136088
- 3006113097
- 1220477
- 3004050854
- 3015225571
- 9680794
- 1250045
- 3006580788
- 3015525200
- 3006260740
- 2135339
- 1066421
- 1417592
- 3001186500
- 3004512585
- 1213643
- 9617592
- 3006324197
- 3002807112
- 3005761322
- 3007829657
- 3027815
- 2245304
- 2032542
- 2135152
- 9612051
- 3012777736
- 3004138549
- 3003775072
- 3031288561
- 3031563325
- 3007663067
- 9680271
- 3012536737
- 3005818605
- 9680091
- 3007583554
- 3010864832
- 3023316
- 3005460813
- 1424263
- 3002807310
- 3045855232
- 3005378067
- 8043396
- 1450662
- 3015309643
- 1018233
- 3007225047
- 3005853033
- 8021832
- 3021841055
- 3010123105
- 3020664666
- 3011088743
- 3032534
- 2032098
- 3017391151
- 3016844359
- 3004111573
- 3009317711
- 3006082230
- 3008298053
- 9616067
- 1223089
- 3011137372
- 1721504
- 1047843
- 2029275
- 1219313
- 1061124
- 3015422337
- 3022104448
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254168 | Actolind® (06.3637. Actolind® Gel Plus) | ACTO GmbH | 2026-09-22 |
| K254041 | SkinSmart Antimicrobial HydroGel | Magic Science Supply, LLC | 2026-09-11 |
| K261646 | Redermax® Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-08-14 |
| K253665 | Vashe Plus Antimicrobial Solution | Urgo Medical North America, LLC | 2026-08-11 |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | 2026-06-24 |
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | 2026-06-17 |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | 2026-05-13 |
| K254191 | IWD-Gel™ | InnovaCorium, Inc. | 2026-04-07 |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | 2026-03-25 |
| K251999 | Promogran Prisma™ Collagen Matrix with ORC and Silver | Solventum Germany GmbH | 2026-03-13 |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026-03-11 |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | 2026-02-02 |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. | 2026-01-23 |
| K250890 | SBC1 Cream | Sioxmed, LLC | 2026-01-12 |
Legacy Summary#
summary
FDA Review#
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