510(k) K161013
- Device
- InnoSEAL Hemostatic Pad
- Applicant
- InnoTherapy Inc.
- 510(k) number
- K161013
- Product code
- FRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-29
- Date received
- 2016-04-11
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Moon Sue Lee
- Address
- Ace Hightechcity2,25, Seonyu-Ro 13-Gil Yeongdeungpo-Gu Seoul KR 07282 07282
FDA Registration Numbers#
- 3038718579
- 2245304
- 1250045
- 3021841055
- 1018233
- 9680794
- 1526711
- 1625425
- 3003775072
- 1061124
- 2032542
- 3009317711
- 3010123105
- 3012536737
- 3004111573
- 3012888343
- 8021832
- 1054811
- 3016844359
- 3001186500
- 3033589330
- 3025413691
- 2183319
- 3022104448
- 2135339
- 3004512585
- 3027517726
- 1038758
- 3027815
- 3015422337
- 3005378067
- 3015437221
- 3006580788
- 1450662
- 9680271
- 3023316
- 3010878315
- 3034735187
- 3006260740
- 3011657181
- 3002807310
- 3015309643
- 3007788086
- 2244725
- 3007663067
- 8043838
- 3004050854
- 1424263
- 3008298053
- 3006619672
- 9616067
- 9614493
- 3005460813
- 8043396
- 1058584
- 3002808227
- 3009348684
- 9612051
- 3011400126
- 1213643
- 3007225047
- 3011137372
- 3007829657
- 1417592
- 9681465
- 3002807112
- 3003767891
- 1223089
- 3031288561
- 3005761322
- 2029275
- 9680091
- 9611590
- 3006082230
- 3015525200
- 3007215524
- 3004957256
- 3005674475
- 3008559295
Source Documents#
Other 510(k) Records For Product Code FRO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252759 | revyve® Antimicrobial Skin and Wound Cleanser | Kane Biotech, Inc. | 2026-01-08 |
| K251757 | Puracyn® Plus Antimicrobial Irrigation Solution | Innovacyn, Inc. | 2026-01-05 |
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025-12-19 |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) | Huizhou Foryou Medical Devices Co., Ltd. | 2025-11-19 |
| K250115 | Hemastyl(™) Wound Dressing | Rapid Nexus Nanotech Wound Solutions, Inc. | 2025-10-14 |
| K251866 | Tegaderm Post-Op Transparent Antimicrobial Dressing | Solventum US, LLC | 2025-10-10 |
| K243166 | Dermalage | Infection Elimination Solutions, LLC | 2025-08-27 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases