COMFEEL WOUND DRESSING SD
FDA 510(k) clearance K922466 · decided 1992-08-17
Clearance details
- K-number
- K922466
- Device name
- COMFEEL WOUND DRESSING SD
- Applicant
- Coloplast A/S
- Decision
- Substantially Equivalent
- Date received
- 1992-05-26
- Decision date
- 1992-08-17
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- KMF
- Device class
- 1
- Regulation number
- 880.5090
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Coloplast A/S
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TearRepair Liquid Skin Protectant (K241916) | Optmed, Inc. | 2024-09-27 |
| Rochal Bioshield Silicone Film (K182733) | Rochal Industries, LLC | 2019-06-27 |
| Aleo BME Liquid Bandage (K171148) | Aleo Bme, Inc. | 2018-01-12 |
| Cavilon Advanced High Endurance Skin Protectant (K153571) | 3M Healthcare | 2016-08-23 |
| Atteris No-Sting Skin Protectant (K160684) | Rochal Industries, LLC | 2016-07-26 |
| KERICURE ADVANCED LIQUID BANDAGE, NATURAL SEAL LIQUID BANDAGE, LIQUID BANDAGE (K131384) | Kericure, Inc. | 2014-08-07 |
| MARATHON NO STING LIQUID SKIN PROTECTANT (K133443) | Advanced Medical Solutions (Plymouth), Ltd. | 2014-07-10 |
| LIQUID BANDAGE (K120059) | Chesson Laboratory Associates, Inc. | 2012-05-17 |
| SKIN BARRIER FILM (K092712) | Lodestar Products, Inc. | 2010-02-23 |
| ECOCEL (K083087) | Polichem S.A | 2009-08-07 |
| CHESSON LABS LIQUID BANDAGE (K083913) | Chesson Laboratory Associates, Inc. | 2009-07-31 |
| GLUSEAL 90, MODEL GLU9010 (K083752) | Glustitch, Inc. | 2009-02-23 |
Recalls involving this device
No recalls on record reference this clearance.