CO2 Rigid Laser Endoscope Probe Series 792/LAPARO
FDA 510(k) K881010 · Sharplan Lasers, Inc.
510(k) numberK881010
Submission
- Device name
- CO2 Rigid Laser Endoscope Probe Series 792/LAPARO
- Applicant
- Sharplan Lasers, Inc.
Allendale, NJ, US - Received
- March 10, 1988
- Decision date
- April 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 CO2 Rigid Laser Endoscope Probe Series 792/LAPARO cleared by the FDA?
CO2 Rigid Laser Endoscope Probe Series 792/LAPARO (K881010) received a 510(k) decision of Substantially Equivalent on April 21, 1988, 42 days after the submission was received.
What is the product code of K881010?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.