Anchor Products Co.
Addison, IL, US
ANCHOR PRODUCTS CO. appears in FDA device records in Addison, IL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Anchor Products Co. between 1979 and 2009. The busiest year on record is 1979, with 1. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1983 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1998 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K091930 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM, MODEL TRS100SB | GCJ | Substantially Equivalent | |
| K061555 | ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM | GCJ | Substantially Equivalent | |
| K982073 | ANCHOR LAPAROSCOPIC TISSUE RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | GES | Substantially Equivalent | |
| K873124 | ANCHOR BIOPSY NEEDLE | GAA | Substantially Equivalent | |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | GAB | Substantially Equivalent | |
| K790405 | ANCHOR BRAND COUNT-TAINER | MMK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1416891 | 1416891 | ANCHOR PRODUCTS CO. | 52 OFFICIAL RD., ADDISON, IL 60101 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GESBlade, Scalpel
- MMKContainer, Sharps
- HAOInstrument, Surgical, Non-Powered
- JYPKnife, Myringotomy
- HNNKnife, Ophthalmic
- GCJLaparoscope, General & Plastic Surgery
- GAANeedle, Aspiration And Injection, Disposable
- HNMNeedle, Ophthalmic Suturing
- GABNeedle, Suturing, Disposable
- GDLNeedle, Suturing, Reusable
- KBRNeedle, Tonsil Suturing
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1591-2011 | Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 15 mm, 1550 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS175SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery. | The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage. | Terminated | ||
| Z-1590-2011 | Anchor Tissue Retrieval System; ETO sterilized, single use disposable device; port size 10 mm, 225 mL capacity; 3 units per box; Manufacturer: Anchor Products Co., 52 Official Rd, Addison, IL 60101 U.S.A.; Ref TRS100SB The device is a single use, sterile disposable pouch used with a dedicated introducer for the capture and removal of tissue or organ from the body cavity during laparoscopic surgery. | The metal component within the unit can break and cause a malfunction. Use of the device may represent a potential health hazard if the metal component is not removed after breakage. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain