Product code GDX
- Device name
- Scalpel, One-Piece
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923689 | SURGISTAR BLADES | Surgistar, Inc. | 1992-09-09 |
| K921167 | ULTRABLADE | Micron Technology, Inc. | 1992-07-30 |
| K914086 | ICAN CYLINDRICAL SPONGES | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| K904505 | CCI CORNEAL SCARIFIER | Buckman Co., Inc. | 1991-04-23 |
| K905380 | 1-CUT ACL GRAFT KNIFE | Depuy, Inc. | 1990-12-13 |
| K895682 | VESSEL LOOPS | Applied Medical Technologies | 1989-10-24 |
| K893033 | MINI-DIAMOND KNIFE | L.A.B. Instruments | 1989-05-26 |
| K880028 | OMED DISPOSABLE SCALPEL | Oxboro Medical Intl., Inc. | 1988-01-29 |
| K871894 | KCK INDUSTRIES' SURGICAL INSTRUMENTS | Kck Industries | 1987-06-23 |
| K863950 | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL | Precision Surgical Industries, Inc. | 1986-10-24 |
| K863213 | KEISEI SCALPEL (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K854857 | SCALPEL, ONE-PIECE, DISPOSABLE | Medelec Intl. Corp. | 1985-12-24 |
| K853103 | MCKNIFE | Medical Dimensions | 1985-08-06 |
| K851751 | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | Artiberia | 1985-06-20 |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Imm Enterprises , Ltd. | 1984-01-27 |
| K833467 | SURE-CUT | Diverse Technologies, Inc. | 1984-01-27 |
| K830745 | ADT DISPOSABLE SCALPEL W/STAINLESS STEEL | Lab Industries, Inc. | 1983-04-12 |
| K822893 | G.E.V. DISPOSABLE SCALPELS | Ascep, Inc. | 1982-10-22 |
| K822749 | PILLING DIAMOND KNIFE | Narco Scientific | 1982-10-06 |
| K820869 | DISPOSABLE #11 SCALPEL BLADE W/SHORT | Van-Tec, Inc. | 1982-05-05 |
| K820730 | MICRO CISE DIAMOND SCALPEL | CooperVision, Inc. | 1982-04-09 |
| K813422 | SCALPEL | Abco Dealers, Inc. | 1982-01-05 |
| K811707 | AXICUT DISPOSABLE SCALPEL | Neonatal Corp. | 1981-07-20 |
| K800177 | I.M. BLADES | Instrument Makar, Inc. | 1980-02-11 |
| K790259 | STERILE DISPOSABLE KNIFE | Intermedics, Inc. | 1979-02-13 |
| K780998 | SCALPEL | Isolab, Inc. | 1978-07-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08902895148312 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895148138 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895148121 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895148114 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895148107 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895148091 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129373 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895148251 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129281 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129243 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129236 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129229 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129212 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-09 |
| 08902895129250 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-07 |
| 08902895129267 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-07 |
| 08902895129205 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-07 |
| 08902895129151 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-07 |
| 08902895129137 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-07 |
| 08902895129120 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-07 |
| 08902895129113 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-06 |
| 08902895129311 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-06 |
| 08902895129106 | KIATO PLUS | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-06 |
| 10192253051858 | Kendall | Cardinal Health 200, LLC | 2024-08-14 |
| 10192253051865 | Kendall | Cardinal Health 200, LLC | 2024-08-14 |
| 10192253051872 | Kendall | Cardinal Health 200, LLC | 2024-08-14 |
| 10192253051827 | Kendall | Cardinal Health 200, LLC | 2024-08-13 |
| 10192253051834 | Kendall | Cardinal Health 200, LLC | 2024-08-13 |
| 10192253051841 | Kendall | Cardinal Health 200, LLC | 2024-08-13 |
| 10193489447873 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |
| 10193489447880 | Medline Industries, Inc. | MEDLINE INDUSTRIES, INC. | 2022-08-04 |