510(k) K041501 ยท MMP Cover, Barrier, Protective
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
| Applicant | Guangzhou Fortunique , Ltd., Chester NY, US |
| Decision | Substantially Equivalent, Nov 30, 2004 |
| Received | Jun 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041501
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2020 | Stryker Corporation Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326 Open, Classified |
MMP | None listed |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.
The SPY-PHI Drape is intended to cov Terminated |
MMP | None listed |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as sing Terminated |
MMP | None listed |
| Jun 27, 2017 | NOVADAQ TECHNOLOGIES INC. NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada.
The SPY-PHI Drape is inten Terminated |
MMP | None listed |
| Jan 23, 2017 | Covidien LLC Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046)
Item Number: 01-0020
Used in conjunction RF Surgical Gauze detection systems to protect scanning dev Terminated |
MMP | None listed |
| Jan 23, 2017 | Covidien LLC Premier Guard Drape, Sterile.
For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044)
Item Number: 01-0037
Used in conjunction RF Surgical Gauze detection systems to protect scanning device from c Terminated |
MMP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.