Birtcher Endoscopic Corkscrew
FDA 510(k) K931771 · Birtcher Medical Systems, Inc.
510(k) numberK931771
Submission
- Device name
- Birtcher Endoscopic Corkscrew
- Applicant
- Birtcher Medical Systems, Inc.
Irvine, CA, US - Received
- April 9, 1993
- Decision date
- April 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
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More from 270surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K932779 | Birtcher Swivel Grip Laparoscopic Probes & Access.HET · Traditional | 03/21/1995SE |
| K944681 | Lectrosurigical, Cutting and Coagulation and AccessoriesGEI · Traditional | 12/22/1994SE |
| K936114 | Birtcher Pericardial KnivesGCJ · Traditional | 04/25/1994SE |
| K932987 | Birtcher Laparoscope and AccessoriesGCJ · Traditional | 04/25/1994SE |
| K931654 | Birtcher Magnetic Retriever (GS-3100)HET · Traditional | 04/25/1994SE |
| K930887 | Birtcher Bronchus & Lung Clamp (GS-1620 & GS-1600)GCJ · Traditional | 04/25/1994SE |
| K933319 | Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization SystemGCY · Traditional | 10/27/1993SE |
| K930302 | Birtcher Sure Clean Instrument SystemGCI · Traditional | 10/27/1993SE |
| K930496 | GI-1090,1095,1080,1085,1086,1088, Endo. ClampsGCI · Traditional | 04/20/1993SE |
| K925824 | Solos Fan RetractorsGCJ · Traditional | 03/01/1993SE |
Questions and answers
When was Birtcher Endoscopic Corkscrew cleared by the FDA?
Birtcher Endoscopic Corkscrew (K931771) received a 510(k) decision of Substantially Equivalent on April 25, 1994, 381 days after the submission was received.
What is the product code of K931771?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.