Product code GES
- Device name
- Blade, Scalpel
- 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 |
|---|---|---|---|
| K032242 | PERSONNA PLUS SAFETY SCALPEL SYSTEM | Omi Manufacturing Pty., Ltd. | 2003-09-23 |
| K932998 | EASY-ON | Devon Industries, Inc. | 1993-08-18 |
| K923170 | LOS ALAMOS RETRACTABLE KNIFE | Innovative Surgical Technology, Inc. | 1993-02-18 |
| K915119 | SCALPEL BLADE REMOVER (BLADEGARD) | Intergrated Visual, Inc. | 1992-05-05 |
| K911913 | PRECISION GLIDE - ENHANCED SURGICAL BLADE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-13 |
| K900266 | STERILE CARBON STEEL SURGICAL BLADE | Rahn Laboratories | 1990-03-01 |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Anchor Products Co. | 1988-12-27 |
| K881638 | SURGICAL BLADE | Far East Intl. Trading Corp. | 1988-06-15 |
| K880244 | SURGICAL BLADES | Ailee C/O Havel'S, Inc. | 1988-02-10 |
| K873493 | NINJA SCALPEL | Primrose Medical, Inc. | 1987-09-24 |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | 1987-09-04 |
| K863885 | SABLE BLADES | Sable Industries | 1986-10-24 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | 1986-01-24 |
| K854860 | BLADES, SCALPEL CARBON STEET | Medelec Intl. Corp. | 1985-12-24 |
| K854859 | BLADES, SCALPEL STAINLESS STEEL | Medelec Intl. Corp. | 1985-12-24 |
| K854620 | SURGICAL BLADES | Niraj Industries | 1985-12-17 |
| K854561 | BLADE, SCALPEL | Medelec Intl. Corp. | 1985-12-02 |
| K853528 | STAINLESS STEEL & CARBON STEEL STERILE BLADES | Abco Dealers, Inc. | 1985-09-24 |
| K852661 | APOLLO STERILE BLADES | Orthofab, Inc. | 1985-07-11 |
| K852141 | STERILE SURGICAL BLADES | Miltex Instrument Co. | 1985-06-13 |
| K851157 | SURGIMED - SURGICAL BLADES | Surgimed Corp. | 1985-04-25 |
| K844759 | SURGICAL SCALPEL BLADES & DISPOSABLES | Cross Country Paper Products Corp. | 1985-01-18 |
| K844001 | LANCE BLADES & SCALPELS | Perry, Div. | 1984-11-08 |
| K841883 | SURGEON'S BLADES STERILE BLADE | An-Med Intl. | 1984-06-05 |
| K841320 | PERCUTANEOUS TRIG. FINGER RELEASE KNIFE | Anapach Effort, Inc. | 1984-04-24 |
| K834514 | FASCIA CUTTER | Stryker Corp. | 1984-03-12 |
| K834195 | JAKOBI SURG. INSTRUMENTS #11 11/13/14 | Imm Enterprises , Ltd. | 1984-01-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08717903490228 | Humeca blade for Silver knife | Humeca B.V. | 2025-05-20 |
| 08717903490242 | Humeca blade for Humby long knife (20cm/7.9 in) | Humeca B.V. | 2025-05-20 |
| 08717903490235 | Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in) | Humeca B.V. | 2025-05-19 |
| 08902895111330 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111309 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111293 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111286 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111279 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111262 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111255 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111248 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111231 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111224 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111217 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111200 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111194 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111156 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111132 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111125 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111118 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08902895111095 | KIATO | ADITYA DISPOMED PRODUCTS PRIVATE LIMITED | 2024-12-05 |
| 08800017901688 | EZ-Blade Remover | DXM CO., LTD | 2023-06-19 |
| H66827013101 | PREHMA | Keystone Industries | 2022-11-30 |
| H66827011101 | PREHMA | Keystone Industries | 2022-11-30 |
| H66827007101 | PREHMA | Keystone Industries | 2022-11-30 |
| H66827005101 | PREHMA | Keystone Industries | 2022-11-30 |
| H66827003101 | PREHMA | Keystone Industries | 2022-11-30 |
| H66827002101 | PREHMA | Keystone Industries | 2022-11-30 |
| H66827001101 | PREHMA | Keystone Industries | 2022-11-30 |
| ESOT001631 | NA | S & T AG | 2022-09-15 |