Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization System
FDA 510(k) K933319 · Birtcher Medical Systems, Inc.
510(k) numberK933319
Submission
- Device name
- Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization System
- Applicant
- Birtcher Medical Systems, Inc.
Braintree, MA, US - Received
- July 7, 1993
- Decision date
- October 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4680
- Specialty
- General, Plastic Surgery
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| 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 |
| K930302 | Birtcher Sure Clean Instrument SystemGCI · Traditional | 10/27/1993SE |
| K930496 | GI-1090,1095,1080,1085,1086,1088, Endo. ClampsGCI · Traditional | 04/20/1993SE |
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Questions and answers
When was Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization System cleared by the FDA?
Birtcher GS-9480 Integrated 3-CHIP Camera/Xenon Light Source Visualization System (K933319) received a 510(k) decision of Substantially Equivalent on October 27, 1993, 112 days after the submission was received.
What is the product code of K933319?
The FDA product code is GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered, a Class I (low risk) device regulated under 21 CFR 878.4680.