Trocar & Trocar Sleeeve 11MM, 10MM, 8MM & 5MM
FDA 510(k) K915297 · Lifeguard Medical Products, Inc.
510(k) numberK915297
Submission
- Device name
- Trocar & Trocar Sleeeve 11MM, 10MM, 8MM & 5MM
- Applicant
- Lifeguard Medical Products, Inc.
River Forest, IL, US - Received
- November 15, 1991
- Decision date
- February 11, 1992
- 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.
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| K013421 | Lifeguard Nasal CPAP Mask and AccessoriesBZD · Traditional | 01/08/2002SE |
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| K920471 | Levy Articulating RetractorGAD · Traditional | 06/23/1992SE |
| K915505 | Regulator FlowmeterCAN · Traditional | 04/22/1992SE |
| K915298 | Suction/Irrigation Cannula; Catlog #532.00GCJ · Traditional | 01/23/1992SE |
| K880958 | Lifeguard Bacterial and Viral FilterCAH · Traditional | 04/27/1988SE |
| K881087 | Lifeguard Single Use Manual ResuscitatorsBTM · Traditional | 04/14/1988SE |
| K881086 | Lifeguard Mouth to Mask ResuscitatorBTM · Traditional | 04/14/1988SE |
| K880959 | Lifeguard Gas Sampling Line for Mass SpectrometryBZO · Traditional | 04/14/1988SE |
| K863711 | Regulator Oxygen MechanicalCAN · Traditional | 01/27/1987SE |
Questions and answers
When was Trocar & Trocar Sleeeve 11MM, 10MM, 8MM & 5MM cleared by the FDA?
Trocar & Trocar Sleeeve 11MM, 10MM, 8MM & 5MM (K915297) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 88 days after the submission was received.
What is the product code of K915297?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.