GES — Blade, Scalpel Class I
FDA product code GES covers "Blade, Scalpel", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GES
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K032242 | omi manufacturing pty | PERSONNA PLUS SAFETY SCALPEL SYSTEM | September 23, 2003 |
| K932998 | devon industries | EASY-ON | August 18, 1993 |
| K923170 | innovative surgical technology | LOS ALAMOS RETRACTABLE KNIFE | February 18, 1993 |
| K915119 | intergrated visual | SCALPEL BLADE REMOVER (BLADEGARD) | May 5, 1992 |
| K911913 | bd becton dickinson vacutainer systems preanalytic | PRECISION GLIDE - ENHANCED SURGICAL BLADE | May 13, 1991 |
| K900266 | rahn laboratories | STERILE CARBON STEEL SURGICAL BLADE | March 1, 1990 |
| K884862 | anchor products | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | December 27, 1988 |
| K881638 | far east intl. trading | SURGICAL BLADE | June 15, 1988 |
| K880244 | ailee c/o havel | SURGICAL BLADES | February 10, 1988 |
| K873493 | primrose medical | NINJA SCALPEL | September 24, 1987 |
| K873142 | american safety razor | PERSONNA DISPOSABLE SCALPEL | September 4, 1987 |
| K863867 | storz instrument | DEXTRA DISPOSABLE BLADES | October 24, 1986 |
| K863885 | sable industries | SABLE BLADES | October 24, 1986 |
| K863211 | keisei medical industrial co | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | September 2, 1986 |
| K863214 | keisei medical industrial co | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | September 2, 1986 |
| K855104 | angiomed u.s | ANGIOMED SKIN FASCIA KNIFE | January 24, 1986 |
| K854859 | medelec intl | BLADES, SCALPEL STAINLESS STEEL | December 24, 1985 |
| K854860 | medelec intl | BLADES, SCALPEL CARBON STEET | December 24, 1985 |
| K854620 | niraj industries | SURGICAL BLADES | December 17, 1985 |
| K854561 | medelec intl | BLADE, SCALPEL | December 2, 1985 |