Anchor Laparoscopic Tissue Retrieval System, Model TRS100SB
FDA 510(k) K091930 · Anchor Products Co.
510(k) numberK091930
Submission
- Device name
- Anchor Laparoscopic Tissue Retrieval System, Model TRS100SB
- Applicant
- Anchor Products Co.
Addison, IL, US - Received
- June 30, 2009
- Decision date
- September 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K061555 | Anchor Laparscopic Tissue Retieval SystemGCJ · Traditional | 08/31/2006SE |
| K982073 | Anchor Laparoscopic Tissue Retrieval SystemGCJ · Traditional | 09/22/1998SE |
| K884862 | Anchor Double-Edge Myringotomy BladeGES · Traditional | 12/27/1988SE |
| K873124 | Anchor Biopsy NeedleGAA · Traditional | 09/08/1987SE |
| K831648 | Anchor Brand Surgical NeedlesGAB · Traditional | 08/16/1983SE |
| K790405 | Anchor Brand Count-TainerMMK · Traditional | 03/26/1979SE |
Questions and answers
When was Anchor Laparoscopic Tissue Retrieval System, Model TRS100SB cleared by the FDA?
Anchor Laparoscopic Tissue Retrieval System, Model TRS100SB (K091930) received a 510(k) decision of Substantially Equivalent on September 23, 2009, 85 days after the submission was received.
What is the product code of K091930?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.