Chrysalis Intelligence · Sponsors · Intersect Ent.

Intersect Ent.

Menlo Park, CA, US · 1 510(k) clearances · 15 PMAs · 1 recalls

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Total clearances
1
2022-02-04 → 2022-02-04
Last 12 months
0
Product codes
1
Most recent
2022-02-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LRC Instrument, Ent Manual Surgical Class I Ear, Nose, Throat 1 2022-02-04
Class III

PMA approvals (15)

Total PMA records
15
Originals + supplements
Distinct product codes
1
First decision
2020-02-28
Most recent
2026-07-31
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-31 P100044-S059 Propel, Propel Mini (including Propel Mini with Straight Delivery System), and Propel Contour Sinus Implants 135 Review Track For 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2025-11-07 P100044-S058 Propel Contour Sinus Implant Real-Time Process OWO Drug-Eluting Sinus Stent Unknown
2025-06-18 P100044-S057 PROPEL, PROPEL MINI and PROPEL CONTOUR 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2025-02-12 P100044-S056 Propel®, Propel® Mini, Propel® Contour Sinus Implants 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2024-11-25 P100044-S055 Propel® Contour Sinus Implant 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2024-10-11 P100044-S054 Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2024-10-02 P100044-S053 Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2024-09-10 P100044-S052 Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS) 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2022-12-22 P100044-S051 Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C 30-Day Notice OWO Drug-Eluting Sinus Stent Unknown
2022-11-04 P100044-S050 Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C Special (Immediate Track) OWO Drug-Eluting Sinus Stent Unknown
2022-06-24 P100044-S049 Propel Contour Sinus Implant Real-Time Process OWO Drug-Eluting Sinus Stent Unknown
2021-04-09 P100044-S048 Propel and Propel Mini Sinus Implants Real-Time Process OWO Drug-Eluting Sinus Stent Unknown
2020-07-01 P100044-S046 Propel Mini Sinus Implant Real-Time Process OWO Drug-Eluting Sinus Stent Unknown
2020-04-24 P100044-S045 Propel Family of Sinus Implants Special (Immediate Track) OWO Drug-Eluting Sinus Stent Unknown
2020-02-28 P100044-S043 Propel Normal 180 Day Track No User Fee OWO Drug-Eluting Sinus Stent Unknown
Safety

Recalls (1)

Class I (serious)
0
Risk of injury / death
Total recalls
1
Currently ongoing
1
Most recent
2022-10-21
DateSeverityStatusRecall # ProductCodeReason
2022-10-21 Class II Ongoing Z-0458-2023 Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044 — Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-02-04 K212774 VenSure LightGuide LRC Class I Ear, Nose, Throat
Data source: openFDA · Generated 2026-08-11 12:14 · Last ingest 2026-08-11T16:13:49.849860 · Pipeline: Chrysalis Intelligence