510(k) Report

510(k) · Cleared

Cleared

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

K163412510(k) TraditionalCleared Jun 22, 2017199-day reviewClass I21 CFR 868.5540

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Girgis Scope, LLC · CCW Laryngoscope, Rigid

Cleared on Jun 22, 2017 as substantially equivalent to K915804 (Propper Mfg. Co., Inc., 1992) after a 199-day review. Its family tree reaches back 1 generation to 1992.

Decided
Jun 22, 2017
Review
199 days
Class
Class I
Product code
CCW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K915804 (1992). No later device cites it as a predicate yet.

K915804 · Propper Laryngoscope Blades W Fiber Optic Illum. · Propper Mfg. Co., Inc. · 1992199019952000200520102015
K915804 · Propper Laryngoscope Blades W Fiber Optic Illum. · Propper Mfg. Co., Inc. · 19920
  1. Root · 1 generation backK915804 Propper Laryngoscope Blades W Fiber Optic Illum.Propper Mfg. Co., Inc. · 1992
  2. This deviceK163412 Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLC · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915804Propper Laryngoscope Blades W Fiber Optic Illum.Propper Mfg. Co., Inc.1992—
0 (this device)K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLC2017—
FIG. 1 — Lineage of K163412, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in CCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K915804Propper Laryngoscope Blades W Fiber Optic Illum.
Summary page 4
…Predicate Device Manufacturer Brand Name Classification Propper Manufacturing Propper Flip‐Tip™ K915804 Company, Inc. Laryngoscope Device Description GSV200.DBL is designed to assist in tracheal intubation procedu…
Propper Mfg. Co., Inc.1992—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All CCW devices

CCW Laryngoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · CCW

1in 2019

2007: 12012: 12014: 12017: 12019: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCW

Too few CCW 510(k)s in any year since 2007 to give a median.

Recalls per year · CCW

4in 2023

2007: 22010: 12011: 22012: 1, 1 Class I2013: 12014: 12015: 32016: 1, 1 Class I2017: 12019: 3, 1 Class I2023: 4, 1 Class I
2007high 4 (2023) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · CCW

1,569in 2025

2007: 62008: 142009: 172010: 262011: 212012: 712013: 3362014: 2022015: 3012016: 8252017: 4142018: 3832019: 3612020: 4962021: 4372022: 3242023: 3462024: 4732025: 1,569
2007high 1,569 (2025) · low 6 (2007)2025

MAUDE reports naming product code CCW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—26
20080—014
20090—017
20100—126
20110—221
20121—1 (1)71
20130—1336
20141—1202
20150—3301
20160—1 (1)825
20171—1414
20180—0383
20191—3 (1)361
20200—0496
20210—0437
20220—0324
20230—4 (1)346
20240—0473
20250—01,569
20260—0—

What is it indicated for?

The Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is indicated to improve direct visualization of

larynx and assist in both non-complicated and difficult intubation in situation of unpredictable airway condition.

Indications for use as stated in the FDA summary.

Recent decisions in CCW

The CCW category page

  • K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd. · 2019
  • K140951Yeescope LaryngoscopesYeescope Pty., Ltd. · 2014
  • K121378Airtraq SP Airtraq AvantProdol Meditec, Ltd. · 2012
  • K063477Novamed Mri Conditional Laryngoscope SetNovamed, LLC · 2007
  • K062523Tru-MR Laryngoscope SetTruphatek International, Ltd. · 20061 recall

https://510kreport.com/device/K163412 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163412: Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163412

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026