MELOLIN
FDA 510(k) clearance K821246 · decided 1982-08-06
Clearance details
- K-number
- K821246
- Device name
- MELOLIN
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-29
- Decision date
- 1982-08-06
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- NAB
- Device class
- 1
- Regulation number
- 878.4014
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IVALON EXTERNAL SPONGE (K946015) | Ivalon | 1995-02-27 |
| ISOLYER (4X4, 8PLY) (K940755) | Isolyer Co. | 1994-05-02 |
| OMNISORB II, NONWOVEN SPONGE, STERILE AND NON (K931610) | Omni Mfg., Inc. | 1993-06-24 |
| MULTI-TRAUMA DRESSING (K925590) | Gam Industries, Inc. | 1993-04-08 |
| K-BAND AND K-CREPE (K926072) | Parema , Ltd. | 1993-03-19 |
| STERILE GAUZE PADS (K915591) | Eagle Medical, Inc. | 1993-01-27 |
| GAUZE SPONGES (K924650) | Dav-Mar Medical Products, Inc. | 1993-01-11 |
| ABSORBENT PAD -- MODIFICATION (K923602) | Winfield Laboratories, Inc. | 1992-12-07 |
| CLINISORB (K923115) | Hermitage Hospital Products, Inc. | 1992-11-23 |
| COMBINE II WETPROOF PAD (K923116) | Hermitage Hospital Products, Inc. | 1992-10-06 |
| USP TYPE VII GAUZE SPONGES (K923378) | E.W.A., Ltd. | 1992-10-06 |
| BURN DRESSING (K923846) | Medical Action Industries, Inc. | 1992-09-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |