Laparoscopy Sets, Needle Holders, Blunt Curved
FDA 510(k) K923260 · Imtec Corp.
510(k) numberK923260
Submission
- Device name
- Laparoscopy Sets, Needle Holders, Blunt Curved
- Applicant
- Imtec Corp.
West Palm Baeach, FL, US - Received
- July 2, 1992
- Decision date
- June 9, 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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Questions and answers
When was Laparoscopy Sets, Needle Holders, Blunt Curved cleared by the FDA?
Laparoscopy Sets, Needle Holders, Blunt Curved (K923260) received a 510(k) decision of Substantially Equivalent on June 9, 1994, 707 days after the submission was received.
What is the product code of K923260?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.