Single Use Laparoscopy Electrosurgical Instrument
FDA 510(k) K914120 · Conmedcorp
510(k) numberK914120
Submission
- Device name
- Single Use Laparoscopy Electrosurgical Instrument
- Applicant
- Conmedcorp
Utica, NY, US - Received
- September 13, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCI – Laryngoscope, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K021747 | Degall Laparoscopic Gallbladder ExtractorGCI · Traditional | Surgicon, Inc. | 08/15/2002SE |
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| K001362 | Karl Storz 3D Video SystemGCI · Traditional | Karl Storz Imaging, Inc. | 07/17/2000SE |
| K933515 | Booty Endoscope WarmerGCI · Traditional | T-Med, Inc. | 10/27/1993SE |
| K930302 | Birtcher Sure Clean Instrument SystemGCI · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K930496 | GI-1090,1095,1080,1085,1086,1088, Endo. ClampsGCI · Traditional | Birtcher Medical Systems, Inc. | 04/20/1993SE |
| K922123 | Auto Suture Disposable Endoscopic Specimen PouchGCI · Traditional | United States Surgical, A Division of Tyco Healthc | 02/01/1993SE |
| K920139 | Gleeson Clot-BusterGCI · Traditional | Conmedcorp | 04/15/1992SE |
| K915762 | Poole Tip Suction ProbeGCI · Traditional | O.R. Concepts, Inc. | 03/13/1992SE |
| K911829 | EndostapleGCI · Traditional | ETHICON, Inc. | 08/28/1991SE |
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| K021079 | Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336XXGEI · Traditional | 07/01/2002SE |
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Questions and answers
When was Single Use Laparoscopy Electrosurgical Instrument cleared by the FDA?
Single Use Laparoscopy Electrosurgical Instrument (K914120) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 47 days after the submission was received.
What is the product code of K914120?
The FDA product code is GCI – Laryngoscope, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.