510(k) K760605
- Device
- LIGHTCAST II CARBIDE BLADE
- Applicant
- MERCK, SHARP & DOHME
- 510(k) number
- K760605
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-10-05
- Date received
- 1976-09-08
- Regulation
- 878.4800
- Classification name
- Blade, Scalpel
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2084346
- 9680890
- 3010692967
- 3002675176
- 3003244954
- 3012366928
- 3015726551
- 3010621964
- 3004899005
- 3004859153
- 9680718
- 3015895045
- 9611680
- 9616250
- 3014383302
- 3033589330
- 1836161
- 1828464
- 8010099
- 9611102
- 9611503
- 1825034
- 3018783415
- 3019356409
- 2936485
- 1423662
- 3023443842
- 1035907
- 3009560891
- 3010864832
- 3003537565
- 1450662
- 9611665
- 1211998
- 3008392711
- 3015177648
- 8022890
- 3011983031
- 3003759558
- 9611579
- 3038718579
- 3039414397
- 3029082594
- 3010220595
- 2183650
- 1420054
- 8010257
- 2083544
- 3005440795
- 3029901632
- 9611283
- 3004530184
- 3035708926
- 3001124136
- 1720929
- 3002692886
- 9615162
- 3002858762
- 1721676
- 3005067367
- 2243072
- 3004215117
- 3004450489
- 3010303097
- 2529846
- 2523320
- 3008808049
- 3016674858
- 3016844398
- 1421879
- 2416465
- 3044819802
- 3008388005
- 3006950086
- 3030447506
- 2032098
- 3007496191
- 8040573
- 3012536737
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GES #
| 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 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 |
| K863885 | SABLE BLADES | Sable Industries | 1986-10-24 |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases