Port-O-Scope(Tm)
FDA 510(k) K895948 · North American Medical Products, Inc.
510(k) numberK895948
Submission
- Device name
- Port-O-Scope(Tm)
- Applicant
- North American Medical Products, Inc.
Loudonville, NY, US - Received
- October 10, 1989
- Decision date
- March 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated…
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| K251731 | KARL STORZ Flexible Intubation Video Endoscope Sterile (FIVE-S) (0916612)EOQ · Special | Karl Storz SE & CO. KG | 12/05/2025SE |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
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| K001965 | Safe-Point Vac, Safe-Point M-D Blood Collection SystemsFMI · Traditional | 02/02/2001SE |
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| K896072 | D.L. Scope OphthalmoscopeHLJ · Traditional | 11/27/1989SE |
| K862661 | D.L. Scope(R) OtoscopeERA · Traditional | 08/08/1986SE |
| K841778 | D.L. Scope Blade & HandleCCW · Traditional | 05/23/1984SE |
Questions and answers
When was Port-O-Scope(Tm) cleared by the FDA?
Port-O-Scope(Tm) (K895948) received a 510(k) decision of Substantially Equivalent on March 27, 1990, 168 days after the submission was received.
What is the product code of K895948?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.