510(k) K822112 ยท HNN Knife, Ophthalmic
OPHTHALMIC KNIFE
| Applicant | Sharpoint, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Aug 10, 1982 |
| Received | Jul 19, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Surgical Specialties Puerto Rico, Inc. Stylus Angled Knife - 52-2835 Clear Corneal Knife, double bevel, parallel sides, angled, full handle, 2.85mm Terminated |
HNN | None listed |
| Jul 20, 2004 | Surgical Specialties Puerto Rico, Inc. Stylus Angled Knife - 56-5361, Pilot Tip Knife, bevel up, angled, full handled, 3.2mm and 56-5161, Pilot Tip Knife, bevel up, angled, full handled, 5.2mm Terminated |
HNN | None listed |
| Jul 20, 2004 | Surgical Specialties Puerto Rico, Inc. Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm
52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm
52-2861, Slit Knife, bevel up, angled, full handled, Terminated |
HNN | None listed |
| Jul 20, 2004 | Surgical Specialties Puerto Rico, Inc. Stylus Brand Angled Knife 52-2931, Slit Knife, double bevel, angled, full handle, 3.0mm
52-3231, Slit Knife, double bevel, angled, full handle, 3.2mm Terminated |
HNN | None listed |
| Jul 20, 2004 | Surgical Specialties Puerto Rico, Inc. Stylus Brand Angled Knife - 54-1010, Sharptome Crescent Knife, bevel up, angled, full handled.
54-1031, Sharptome Crescent Knife, double bevel, angled, full handled Terminated |
HNN | None listed |
| Jul 20, 2004 | Surgical Specialties Puerto Rico, Inc. Stylus Brand Angled Knives - 52-2912, Slit Knife, parallel sides, bevel up, angled, full handle, 3.0mm
52-3212, Slit Knife, parallel sides, bevel up, angled, full handle, 3.2mm Terminated |
HNN | None listed |
| Oct 15, 2003 | Surgical Specialties Corp Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives. Terminated |
HNN | None listed |
| Jun 5, 2003 | Surgical Specialties Puerto Rico, Inc. 2.75 mm Slit Knife, Angled, Bevel Up. Labeled '' Stylus *** 2.75 mm Slit Knife Angled, Bevel, Up***One Unit STERILE R Disposable***Surgical Specialties Corporation***Reading, PA 19606***'' Terminated |
HNN | None listed |
| Apr 1, 2003 | Surgical Specialties Corp Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm. Terminated |
HNN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.