USA Series Laparoscopes
FDA 510(k) K013165 · Circon Acmi
510(k) numberK013165
Submission
- Device name
- USA Series Laparoscopes
- Applicant
- Circon Acmi
Stamford, CT, US - Received
- September 21, 2001
- Decision date
- January 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K261614 | LED LCD Monitor (OEV-271H)GCJ · Traditional | Lg Electronics.Inc | 07/17/2026SE |
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| K260710 | FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…GCJ · Traditional | FloShield, Inc. | 06/11/2026SE |
| K260414 | Tech-Image Video Endoscope SystemGCJ · Traditional | Tech-Image CO., LTD. | 06/10/2026SE |
| K253994 | TroKit Laparoscope Lens WiperGCJ · Traditional | TroCare, LLC | 06/04/2026SE |
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|---|---|---|
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| K905705 | Lap 3501 High Flow InsufflatorHIF · Traditional | 02/28/1991SE |
| K884097 | Morris Anti-Splatter Device for EndoscopesODC · Traditional | 04/17/1989SE |
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| K884254 | Circon Acmi Bicap III Therapeutic SystemKNS · Traditional | 01/11/1989SE |
| K884252 | Circon Acmi Bicap Hemorrhoid System BH-10 & BHP-20KNS · Traditional | 01/10/1989SE |
| K884306 | Bicap Ablating Forceps BAF-7KNS · Traditional | 01/05/1989SE |
| K883819 | Bullard Intubating Laryngoscope Lar-A & Lar-PCCW · Traditional | 10/17/1988SE |
Questions and answers
When was USA Series Laparoscopes cleared by the FDA?
USA Series Laparoscopes (K013165) received a 510(k) decision of Substantially Equivalent on January 18, 2002, 119 days after the submission was received.
What is the product code of K013165?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.