Insufflator Tubing Kit
FDA 510(k) K922197 · O.R. Concepts, Inc.
510(k) numberK922197
Submission
- Device name
- Insufflator Tubing Kit
- Applicant
- O.R. Concepts, Inc.
Roanoke, TX, US - Received
- May 11, 1992
- Decision date
- September 24, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIG – Insufflator, Hysteroscopic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1700
- Specialty
- Obstetrics/Gynecology
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| K935645 | Flowgun Reusable Irrigation ProbesGCJ · Traditional | 03/07/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K932449 | Dr. FogOCT · Traditional | 08/11/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
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Questions and answers
When was Insufflator Tubing Kit cleared by the FDA?
Insufflator Tubing Kit (K922197) received a 510(k) decision of Substantially Equivalent on September 24, 1993, 501 days after the submission was received.
What is the product code of K922197?
The FDA product code is HIG – Insufflator, Hysteroscopic, a Class II (moderate risk) device regulated under 21 CFR 884.1700.