Crawford Lacrimal Intubation Set
FDA 510(k) K800089 · Jedmed Instrument Co.
510(k) numberK800089
Submission
- Device name
- Crawford Lacrimal Intubation Set
- Applicant
- Jedmed Instrument Co.
Walker, MI, US - Received
- January 14, 1980
- Decision date
- March 3, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNL – Probe, Lachrymal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843491 | Concept Fiber Optic Canaliculus IntubaHNL · Traditional | Concept, Inc. | 10/05/1984SE |
| K840861 | Tse-Anderson Modified Lacrimal GroovHNL · Traditional | Hansen Ophthalmic Development Lab | 05/09/1984SE |
| K833671 | Sterile Oil and GuidewireHNL · Traditional | CooperVision, Inc. | 01/10/1984SE |
| K831901 | Lacimal Intubation SetsHNL · Traditional | Visitec Co. | 07/12/1983SE |
| K813187 | Pilling Lacrimal Intubation SystemHNL · Traditional | Narco Scientific | 01/28/1982SE |
| K812255 | Ethicon Lacrimal StentHNL · Traditional | ETHICON, Inc. | 08/20/1981SE |
| K802845 | Concept Canaliculus Intubation SetHNL · Traditional | Concept, Inc. | 12/17/1980SE |
| K801232 | Jackson Lacrimal Intubation SetHNL · Traditional | Storz Instrument Co. | 06/17/1980SE |
| K770194 | Naso-Lacrimal Duct InsertHNL · Traditional | Concept, Inc. | 02/14/1977SE |
More from Concept, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | 07/23/2015SE |
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | 02/21/2014SE |
| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | 06/21/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
Questions and answers
When was Crawford Lacrimal Intubation Set cleared by the FDA?
Crawford Lacrimal Intubation Set (K800089) received a 510(k) decision of Substantially Equivalent on March 3, 1980, 49 days after the submission was received.
What is the product code of K800089?
The FDA product code is HNL – Probe, Lachrymal, a Class I (low risk) device regulated under 21 CFR 886.4350.