Pilling Lacrimal Intubation System
FDA 510(k) K813187 · Narco Scientific
510(k) numberK813187
Submission
- Device name
- Pilling Lacrimal Intubation System
- Applicant
- Narco Scientific
Mchenry, IL, US - Received
- November 16, 1981
- Decision date
- January 28, 1982
- 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 |
| 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 |
| K800089 | Crawford Lacrimal Intubation SetHNL · Traditional | Jedmed Instrument Co. | 03/03/1980SE |
| K770194 | Naso-Lacrimal Duct InsertHNL · Traditional | Concept, Inc. | 02/14/1977SE |
More from Concept, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830338 | Narcotrace 80DXN · Traditional | 12/22/1983SE |
| K831429 | AS 191 ECG Telemetry ModuleDPS · Traditional | 10/14/1983SE |
| K831428 | AS 1740 Interface ModuleDRT · Traditional | 10/14/1983SE |
| K822835 | PZ-800 Volume VentilatorCBK · Traditional | 09/29/1983SE |
| K831430 | Air Shields AS-100 Monioring SYS-AS105DRT · Traditional | 09/12/1983SE |
| K831460 | AS 30/TCP ModuleKLK · Traditional | 07/12/1983SE |
| K830123 | Disp. Yankaver Surg. Suction InstrumentGCY · Traditional | 06/08/1983SE |
| K831028 | TI-1000 Transport IncubatorFPL · Traditional | 05/09/1983SE |
| K823899 | Infant Care SystemFMI · Traditional | 04/14/1983SE |
| K830680 | Air-Shields Ventimeter Ventilator-ContrBSZ · Traditional | 04/08/1983SE |
Questions and answers
When was Pilling Lacrimal Intubation System cleared by the FDA?
Pilling Lacrimal Intubation System (K813187) received a 510(k) decision of Substantially Equivalent on January 28, 1982, 73 days after the submission was received.
What is the product code of K813187?
The FDA product code is HNL – Probe, Lachrymal, a Class I (low risk) device regulated under 21 CFR 886.4350.