510(k) K882742
- Device
- FIBER OPTIC LIGHT SOURCE CAT. #E9100
- Applicant
- VALLEYLAB, INC.
- 510(k) number
- K882742
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-18
- Date received
- 1988-07-01
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PEGGY WALLINE
- Address
- 5920 Longbow Dr. Boulder CO US 80301 80301
FDA Registration Numbers#
- 3010816547
- 1824199
- 3007748817
- 3016851379
- 3020904959
- 3021008900
- 3010805941
- 1418975
- 3007593903
- 3007648309
- 3030446844
- 2650143
- 3005467144
- 2183319
- 3006546082
- 3015241782
- 1828132
- 3008114965
- 3010400367
- 3008933393
- 8010273
- 3006990600
- 1717344
- 8030607
- 3032391
- 3012322232
- 9613563
- 1519132
- 1218017
- 2133936
- 3016168848
- 3011782009
- 3006555617
- 3013944123
- 2022435
- 9611516
- 3021632375
- 2649614
- 3009212837
- 1225492
- 3013077751
- 2953359
- 2242352
- 3010069773
- 3020968442
- 1643817
- 3012204368
- 3017892510
- 3009495876
- 3002807090
- 3008998256
- 3010273872
- 3003174284
- 3003955307
- 3039357913
- 8010890
- 8010871
- 3009103001
- 3007014520
- 1527736
- 8010591
- 3014262693
- 2133772
- 3033511105
- 8043792
- 3027645761
- 3005061536
- 3016248634
- 3006985208
- 3013868968
- 2183870
- 3009756327
- 8010047
- 3009973505
- 3002250546
- 3009420598
- 2530138
- 3041276883
- 3021226419
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEI #
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|---|---|---|---|
| K254196 | HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) | Ethicon Endo-Surgery, LLC | 2026-09-17 |
| K261959 | Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102) | Stryker Instruments | 2026-09-17 |
| K261070 | LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coated | Covidien, LLC | 2026-09-15 |
| K254185 | Potenza Prime | Jeisys Medical Incorporated | 2026-09-11 |
| K262364 | Ellian Enigma RF Device | Ellian Corp | 2026-09-02 |
| K253859 | Scarlet Pro (Scarlet Pro) | VIOL Co., Ltd. | 2026-08-27 |
| K252535 | Inno-Switch™ Laparoscopic Instruments | Taiwan Surgical Corporation | 2026-08-25 |
| K261179 | AlphaTriPart - Monopolar MIC Instruments | Gimmi GmbH | 2026-07-22 |
| K253504 | Volnewmer™ | Classys, Inc. | 2026-07-13 |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS) | Olympus Medical Systems Corp. | 2026-07-01 |
| K251492 | Irrigation Tubing Bipolar Cord Set | New Deantronics Taiwan , Ltd. | 2026-06-29 |
| K253484 | LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | 2026-06-29 |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | Stryker Sustainability Solutions | 2026-06-18 |
| K253634 | CoolSeal Generator® (CSL-200-90) | Hologic, Inc. | 2026-06-17 |
| K261833 | NEUROMARK System (NMK00301) | Neurent Medical , Ltd. | 2026-06-16 |
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