510(k) K900957
- Device
- GS-2100 HOOK SUTURE SCISSOR, 5MM
- Applicant
- SOLOS ENDOSCOPY, INC.
- 510(k) number
- K900957
- Product code
- LRW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-18
- Date received
- 1990-02-27
- Regulation
- 878.4800
- Classification name
- Scissors, General, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEILA H HOLMES
- Address
- 6191 Atlantic Blvd. Suite 4 Norcross GA US 30071 30071
FDA Registration Numbers#
- 3006487092
- 3013901429
- 1423537
- 9614093
- 1519132
- 3008017452
- 3015512299
- 3008711893
- 3005809810
- 3008953712
- 3017417635
- 3036795921
- 3016248634
- 1055890
- 3012656745
- 1223656
- 1450019
- 1421101
- 3015895045
- 9680059
- 3021680161
- 3008467060
- 9613183
- 1054241
- 2245304
- 1928237
- 3002808270
- 8010733
- 9611273
- 3003696170
- 8010273
- 3002769835
- 1032347
- 9611502
- 1528440
- 8040179
- 3007728276
- 3010455030
- 3010055973
- 3032109
- 1422598
- 8043507
- 3008386507
- 3004598675
- 3007597038
- 3015393204
- 3008797953
- 3007589150
- 8043467
- 3002807115
- 2126670
- 2084346
- 3003803182
- 3005621335
- 3015416207
- 3002761766
- 3011625373
- 1820334
- 3012309743
- 3006142527
- 3005194291
- 8040263
- 9680304
- 3005440795
- 3010328449
- 1038758
- 3007518347
- 3030839824
- 1926681
- 3008338766
- 1422443
- 1828464
- 2320762
- 3003431869
- 3004215117
- 3034688516
- 3029082594
- 2916714
- 3006410968
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K911158 | MICRO SCISSORS, 5MM CURVE MICRO SCISSORS, 5MM | Northgate Technologies, Inc. | 1991-03-29 |
| K902828 | SUTURE REMOVAL TRAY | Orion Life Systems, Inc. | 1990-08-08 |
| K900950 | GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM | Solos Endoscopy, Inc. | 1990-04-18 |
| K892823 | PLASTER CUTTING SCISSORS | The South India Surgical Co. Pvt. , Ltd. | 1989-05-25 |
| K891889 | OLIVECORONA SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K891886 | SCISSORS, VARIOUS TYPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K891200 | RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS | Zinnanti Surgical Instruments, Inc. | 1989-04-06 |
| K891203 | SCISSORS: THOREK, JORGENSEN, FINOCHIETTO | Zinnanti Surgical Instruments, Inc. | 1989-04-06 |
| K890235 | DRESSING SCISSORS | Kinetic Medical Products | 1989-02-03 |
| K890170 | SCISSORS | Dhason Brothers, Inc. | 1989-02-03 |
| K890264 | STRABISMUS SCISSORS | Kinetic Medical Products | 1989-01-27 |
| K884373 | KORBER ARTERIOTOMY SCISSORS | Micrins, Ltd. | 1988-11-08 |
| K884095 | SCISSORS, WIRE CUTTING | Magnatrade Corp. | 1988-10-19 |
| K873046 | OVONIC COATED SURGICAL SCISSORS | Micrins, Ltd. | 1987-08-26 |
| K871923 | MICRO SCISSOR, 1.7MM | Arthropedics, Inc. | 1987-06-01 |
Legacy Summary#
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FDA Review#
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